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Acupuncture for Perceived Stress in Military Personnel

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ClinicalTrials.gov Identifier: NCT03364361
Recruitment Status : Completed
First Posted : December 6, 2017
Last Update Posted : March 29, 2018
Sponsor:
Collaborator:
Vanderbilt University
Information provided by (Responsible Party):
Jane J. Abanes, United States Naval Medical Center, San Diego

Brief Summary:

Introduction: Although the physiologic response to stress is necessary for mammals to survive, prolonged stress response as a result of perceived stress can lead to allostatic load and loss of resilience to future stressors. To mitigate the consequences of allostatic load, researchers have investigated the effects of acupuncture as a promising intervention.

Objectives/Aims: The purpose of this study is to explore the feasibility and effect of a standardized stress acupuncture (SSA) approach on perceived stress in U.S. military personnel. Specific aims include the following: a) to determine feasibility of recruitment for SSA and implementation of study procedures in preparation for a methodologically rigorous study, b) to determine the acceptability of SSA treatment in a sample of military personnel with perceived stress, and c) to assess perceived stress and general health before and after SSA.

Methods and Analysis: This is a single-arm, single-site study protocol to assess feasibility of SSA in a total of 15 patients with perceived stress. Upon IRB approval and written informed consent, the participants will receive 4 weekly sessions of SSA which consists of 6 acupuncture points. Demographic information and attrition of participants will be monitored throughout the study. Patient-reported questionnaires including Acupuncture Expectancy Scale, Perceived Stress Scale, and SF-36 will be administered at baseline and then at the completion of the study. Descriptive statistics, reliable change indices (RCI), and Wilcoxon Signed-Ranks tests will be conducted to assess the magnitude of changes in scores.

Military Relevance: The three most common disability conditions in the military include musculoskeletal, psychiatric, and neurological body systems. Among these problems, however, mental health disorders remain a significant contributor to disability and suicide. Given the role of perceived stress in disability and suicidality in the military, intervening early before service members become at risk for severe injuries, hospitalizations, and chronic disability could help decrease burdensome problems.


Condition or disease Intervention/treatment Phase
Acupuncture Perceived Stress Military Personnel Procedure: Acupuncture Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Acupuncture for Perceived Stress in Military Personnel: A Feasibility Study
Actual Study Start Date : February 12, 2018
Actual Primary Completion Date : March 16, 2018
Actual Study Completion Date : March 16, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Acupuncture
Feasibility Study
Procedure: Acupuncture
Participants will receive a six-point standardized stress acupuncture (SSA) treatment once a week for 4 weeks. The SSA consists of GV- 20, GV-24.5 (Yin Tang), bilateral LI-4, and bilateral LR-3. This acupuncture protocol has been used as an effective treatment for stress-related symptoms in the operational theater.




Primary Outcome Measures :
  1. Descriptive statistics and Qualitative Text Summary [ Time Frame: Throughout the study (4 weeks) ]
    Descriptive statistics will be used to describe the following: a) the sample, b) critical demographic, and service information of the participants, c) the number of individuals screened for the study versus the number of participants, and d) the number of participants who completed all visits versus the number of participants who withdrew from the study. The analysis of this aim will be qualitative in nature. At the end of the study, a text summary of feasibility of study procedures will be provided to delineate field notes and lessons learned in the implementation of this study.


Secondary Outcome Measures :
  1. Acupuncture Expectancy Scale (AES) [ Time Frame: Baseline and posttreatment measure at week 4. ]
    The AES is a 4-item questionnaire that measures the participants' expected responses to acupuncture. Participants' expected improvement from acupuncture is rated in a 5-point Likert-type scale ranging from not at all agree to completely agree (Mao et al., 2010). The total possible scores for AES range from 4 to 20, with higher scores indicating greater expectancy. In an initial validation, the instrument's Cronbach's alpha is .82 (Mao et al., 2007). The AES has been found to be reliable, valid, and has acceptable sensitivity to change during treatment starting at week 4 of treatment with increasing statistically significant changes with more acupuncture treatments (Mao et al., 2010).

  2. Perceived Stress Scale (PSS) [ Time Frame: Baseline and posttreatment measure at week 4. ]
    The PSS is a 10-item scale that has been used to evaluate perceived stress experience in adults (Cohen et al., 1983). Perceived general stress is rated in a 5-point Likert-type scale ranging from a never to very often. The total possible scores for PSS range from 0 to 56, with higher scores indicating higher stress. In a normative sample, the instrument's Cronbach's alpha is from .84 to .86 (Cohen et al., 1983).

  3. Short Form-36 Health Survey [ Time Frame: Baseline and posttreatment measure at week 4. ]
    The SF-36 is a 36-item scale that measures the multidimensional concept of health including perceptions about general health, physical health, mental health, and social functioning (Ware & Sherbourne, 1992). The questionnaire has been widely used in both clinical practice and research including in a sample of veterans (Kazis et al., 2004). The instrument has an internal consistency ranging from .52 to .89 (Kazis et al., 2004). This measure has moderate sensitivity in detecting changes in group scores using all SF-36 subscales (Busija, Osborne, Nilsdotter, Buchbinder, & Roos, 2008).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Active duty service members will be considered eligible upon meeting the following criteria: 18 to 65 years of age, Self-report of perceived stress for at least one month. A score of 16 or above on the PSS. The choice of 16 on the PSS scale, as an eligibility criterion, was based on previous studies that use the same score criterion to describe the impact of perceived stress on allostatic load and the effect of acupuncture for perceived stress (Groer et al., 2016; Schroeder et al., 2017). Stable on psychiatric and other medications for at least three months. Able to sign an informed consent.

Exclusion Criteria:

  • Recent medical surgery within one month; Alcohol abuse or dependence diagnosis within one month and active substance use/abuse/dependency treatment within one month; Pregnant women. Acupuncture can result in an induction of labor and spontaneous abortion in rare occasions(White et al., 2008); Has had acupuncture treatment in the past month.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03364361


Locations
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United States, California
Naval Medical Center
San Diego, California, United States, 92134
Sponsors and Collaborators
United States Naval Medical Center, San Diego
Vanderbilt University

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Responsible Party: Jane J. Abanes, Principal Investigator, United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier: NCT03364361     History of Changes
Other Study ID Numbers: NHCP. 2017.0057
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No